Minne Ties Agile MMF MT-1002

GUDID 00850043178026

Minne Ties Sterile Medium Two Pack: Two Medium Sutures of the Same Size (.7 mm/21 ga)

Invisian Medical, LLC

Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set Temporary maxillomandibular fixation set

• Primary Device ID: 00850043178026
• NIH Device Record Key: 913b9f83-add5-4655-beaa-904e1256edaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Minne Ties Agile MMF
• Version Model Number: MT-1002
• Catalog Number: MT-1002
• Company DUNS: 117404743
• Company Name: Invisian Medical, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com
• Phone: 9132281857
• Email: customerservice@minneties.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850043178026 [Primary]
GS1	00860000906029 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162046

FDA Product Code

• DYX: Lock, Wire, And Ligature, Intraoral

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-11
• Device Publish Date: 2022-07-01

On-Brand Devices [Minne Ties Agile MMF]

• 00850043178026: Minne Ties Sterile Medium Two Pack: Two Medium Sutures of the Same Size (.7 mm/21 ga)
• 00850043178019: Minne Ties Sterile Large Two Pack: Two Large Sutures of the Same Size (1.0 mm/18 ga)
• 00850043178002: Minne Ties Kit: Eight (1.0 mm/18 ga), Four (0.7mm/21 ga) & One Cheek Retractor